Equetro

Equetro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Equetro (carbamazepine xr) is used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. It is also used to treat bipolar disorder. It is an anticonvulsant (anti-seizure) medication. Common side effects include nausea, vomiting, dizziness, drowsiness, or unsteadiness as your body adjusts to this medication.

The recommended initial dose of Equetro is 400 mg/day given in divided doses, twice daily. Many other medicines could cause a drug interaction if taken together with Equetro. Tell your doctor all medications and supplements you use. During pregnancy, Equetro should be used only when prescribed. It may harm a fetus. Since untreated bipolar disorder or seizures can be serious conditions, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, consult your doctor. If you are pregnant, prenatal care including tests for defects is recommended. Birth control pills, patches, implants, and injections may not work if taken with this medication. Discuss birth control with your doctor. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Equetro (carbamazepine xr) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Equetro in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • fever, tired feeling, weakness, confusion, pale skin, feeling light-headed or short of breath;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • slow, fast, or pounding heartbeats;
  • confusion, vision problems, hallucinations;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • little or no urinating;
  • swelling, rapid weight gain;
  • problems with your fingernails or toenails; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • dizziness, drowsiness,
  • nausea, vomiting, feeling unsteady;
  • dry mouth, swollen tongue; or
  • loss of balance or coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Equetro (Carbamazepine XR) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Equetro Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, dizziness, drowsiness, constipation, dry mouth, or unsteadiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mouth sores, swollen lymph nodes, persistent vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine, change in the amount of urine, persistent or severe headache, fainting, fast/slow/irregular heartbeat, unusual eye movements (nystagmus), vision changes (such as blurred vision), joint pain, swelling of the ankles/feet, pain/redness/swelling of the arms or legs, numbness/tingling of the hands/feet, sun sensitivity, signs of low levels of sodium in the blood (such as persistent nausea, extreme drowsiness, mental/mood changes including confusion, seizures).

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Equetro (Carbamazepine XR)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Equetro FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

General

The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic system and skin (see BOXED WARNING) and in the cardiovascular system.

The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.

The most commonly observed adverse experiences (5% and at least twice placebo) seen in association with the use of EQUETRO® (400 to 1600 mg/day, dose adjusted in 200 mg daily increments in week 1 in Bipolar I Disorder in the double-blind, placebo-controlled trials of 3 weeks' duration) are included in Table 1 below:

Table 1: Most Common Adverse Events Reported in Double-Blind, Placebo-Controlled Trials (Incidence ≥ 5% and at Least Twice Placebo)

Adverse Events EQUETRO®
(N = 251)
Placebo
(N = 248)
DIZZINESS 44% 12%
SOMNOLENCE 32% 13%
NAUSEA 29% 10%
VOMITING 18% 3%
ATAXIA 15% 0%
PRURITUS 8% 2%
DRY MOUTH 8% 3%
AMBLYOPIA* 6% 2%
SPEECH DISORDER 6% 0%
* Reported as blurred vision

EQUETRO® and placebo-treated patients from two of the double-blind, placebo-controlled studies were enrolled in a 6-month open-label study. Table 2 below summarizes the most common adverse events with an incidence of 5% or more.

Table 2: Most Common Adverse Events Reported in Open-Label Trials (Incidence ≥ 5%)

Body as a Whole % events reported Nervous System % events reported
Headache 22% Dizziness 16%
Infection 12% Somnolence 12%
Pain 12% Amnesia^ 8%
Asthenia 8% Anxiety 7%
Accidental Injury 7% Depression* 7%
Chest Pain 5% Manic Depressive Reaction 7%
Back Pain 5% Ataxia 5%
Digestive Skin Appendages
Diarrhea 10% Rash 13%
Dyspepsia 10% Pruritus 5%
Nausea 10%    
Constipation 5%    
^ Amnesia includes poor memory, forgetful, and memory disturbance.
* Depression includes suicidal ideation.

Other significant adverse events seen in less than 5% of patients include: Suicide Attempt, Manic Reaction, Insomnia, Nervousness, Depersonalization and Extrapyramidal Symptoms, Infections (Fungal, Viral, Bacterial), Pharyngitis, Rhinitis, Sinusitis, Bronchitis, Urinary Tract Infection, Leukopenia and Lymphadenopathy, Liver Function Tests Abnormal, Edema, Peripheral Edema, Allergic Reaction, Photosensitivity Reaction, Alopecia, Diplopia, and Ear Pain.

The following additional adverse reactions were previously reported with carbamazepine:

Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria.

Skin: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, and diaphoresis. In certain cases, discontinuation of therapy may be necessary. Isolated cases of hirsutism have been reported, but a causal relationship is not clear.

Cardiovascular System: Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism, and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis.

Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.

Genitourinary System: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported.

Testicular atrophy occurred in rats receiving carbamazepine orally from 4-52 weeks at dosage levels of 50-400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg/day and higher. Relevance of these findings to humans is unknown.

Nervous System: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, and hyperacusis.

There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established.

Isolated cases of neuroleptic malignant syndrome have been reported with concomitant use of psychotropic drugs.

Digestive System: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia,and dryness of the mouth and pharynx, including glossitis and stomatitis.

Eyes: Scattered punctate cortical lens opacities, as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes.

Musculoskeletal System: Aching joints and muscles, and leg cramps.

Metabolism: Fever and chills and inappropriate antidiuretic hormone (ADH) secretion syndrome have been reported. Cases of frank water intoxication, with decreased serum sodium (hyponatremia) and confusion, have been reported in association with carbamazepine use (see PRECAUTIONS, Laboratory Tests). Decreased levels of plasma calcium have been reported.

Other: Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants.

A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Drug Abuse And Dependence

No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

Read the entire FDA prescribing information for Equetro (Carbamazepine XR) »

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Equetro - User Reviews

Equetro User Reviews

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Here is a collection of user reviews for the medication Equetro sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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